Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice

NCT02518763 | Unknown Phase 3

• 1 other identifier: 08-090
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years \[5\]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Serum 25 OH vitamin D concentration

  4 weeks

Study Arms (1)

Vitamin D3, 100 000 IU weekly, 4 times

EXPERIMENTAL

Drug: Vitamin D3, 100 000 IU weekly, 4 times; Biological: 25 OH vitamin D serum concentration measurements

Interventions

Vitamin D3, 100 000 IU weekly, 4 times DRUG

Vitamin D3, 100 000 IU weekly, 4 times

25 OH vitamin D serum concentration measurements BIOLOGICAL

Vitamin D3, 100 000 IU weekly, 4 times

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women ≥ 50 years
• Osteoporosis with BMD T-score ≤ -2.7DS -2.5DS to at least one of the two main sites analyzed, with or without fracture
• having signed an informed consent

You may not qualify if:

• Taking an osteoporosis treatment combined with vitamin D in the same tablet (or Adrovance Fosavance \* \*)
• Treatment with thiazide diuretic
• Known malabsorption (celiac disease)
• Scalable Endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism.
• Persistent or nephrolithiasis occurred in the previous 5 years
• known sarcoidosis
• Persons under guardianship or trusteeship
• Hypercalcemia and hypercalciuria
• OH vitamin D levels\> 50ng / ml

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital

Caen, 14000, France

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 10, 2015
• Study Start: June 1, 2011
• Primary Completion: December 1, 2015
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

FR (1)